BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MODULAR HEAD

    MDR report key: 1896132 · Received November 10, 2010

    Report

    Report Number
    1825034-2010-00522
    Event Type
    Injury
    Date Received
    November 10, 2010
    Report Date
    October 12, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, #8 STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY MAY ALSO CONTRIBUTE TO THESE CONDITIONS." THE DEVICE IDENTIFICATION WAS NOT PROVIDED AND, THEREFORE, REVIEW OF DEVICE HISTORY RECORDS WAS NOT POSSIBLE. THIS REPORT SUBMITTED (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A SCHOLARLY JOURNAL THAT PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY IN (B)(6) 2004. SUBSEQUENTLY, THE PATIENT WAS REVISED IN (B)(6) 2007, DUE TO SUBLUXATION AND GROIN PAIN. THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN MODULAR HEAD PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R